| Primary Device ID | 00850005084792 |
| NIH Device Record Key | 2e8c9bd3-91b4-41fb-8bf9-fc507b89c504 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | PI-3305 |
| Company DUNS | 621872006 |
| Company Name | PACIFIC INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005084792 [Primary] |
| HWR | Driver, Prosthesis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
[00850005084792]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-06 |
| Device Publish Date | 2024-07-29 |
| 00810168190136 - NA | 2025-07-18 Nonparallel Distractor for up to 6.0mm Rod |
| 00810168190143 - NA | 2025-07-18 Nonparallel Compressor for up to 6.0mm Rod |
| 00810168190075 - NA | 2025-07-03 5x8mm Cup Curette, Straight |
| 00810168190099 - NA | 2025-07-03 5x8mm Cup Curette, Angled Up |
| 00810168190129 - NA | 2025-07-03 Scalpel Handle, 8 Inch |
| 00810168190112 - NA | 2025-05-30 Distraction Screw, 14mm |
| 00850005084952 - NA | 2025-04-25 12 Inch Scalpel |
| 00850005084969 - NA | 2025-04-25 6.0 Double Action Rod Gripper |